Zoll-Dental

#1 Glick (Blade & Plugger)

Registry build 21.09.26
5manufacturers in China registered for this device type
28catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Hubei (1).

Chinese manufacturers registered for FDA product code EKC
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Hubei Lanbin Medical Group Co., Ltd. Xiaogan Hubei Contract manufacturer 33
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28

Record

Regulatory record for Zoll-Dental
Listed by Zoll-Dental
FDA product code EKC
Device type Excavator, Dental, Operative
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2020-03-13
Record revised 2021-11-18 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Zoll-Dental
Catalogue number Size Status
OPEXC-6 In distribution
OPEXC-31W In distribution
OPEXC-17 In distribution
OPEXC-Glick-1 In distribution
OPEXC-61/62 In distribution
OPEXC-19 In distribution
OPEXC-32L In distribution
OPEXC-SP In distribution
OPEXC-1 In distribution
OPEXC-3 In distribution
OPEXC-65/66 In distribution
OPEXC-Glick-2 In distribution
OPEXC-2 In distribution
OPEXC-17W In distribution
OPEXC-36/37 In distribution
OPEXC-40/41 In distribution
OPEXC-33L In distribution
OPEXC-18W In distribution
OPEXC-19W In distribution
OPEXC-18 In distribution
OPEXC-31L In distribution
OPEXC-ZAAE In distribution
OPEXC-38/39 In distribution
OPEXC-44/45 In distribution
OPEXC-14 In distribution
OPEXC-4 In distribution
OPEXC-246 In distribution
OPEXC-63/64 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 193
Nordent Manufacturing Inc Nordent Manufacturing Inc 149
Integra® Miltex® Integra LifeSciences Production Corporation 59
Brasseler USA Peter Brasseler Holdings, LLC 44
A. Titan Instruments A. Titan Instruments, Inc. 43
Excavator Double Ended Maillefer Instruments Holding Sàrl 36
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 35
Power Dental USA Power Dental U.S.A. Inc. 34
Premier Excavators Premier Dental Products Co. 30
Kohdent Kohler Medizintechnik GmbH 27
Darby Dental Supply, LLC Darby Dental Supply, LLC 27
Osung MND Osung MND Co., Ltd. 24

Showing 12 of 52. All products under Excavator, Dental, Operative

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer